The horizontal screw centrifuge is a widely used machine in the industrial forest field, and the decanter centrifuge can be seen in many places. Although the use of decanter centrifuges is relatively extensive, there are still many people who do not understand decanters.
(1) Purification, cleaning and sterilization: Purification has two meanings for the equipment, that is, the equipment itself does not pose pollution to the production environment and does not pose a threat to the safety of the drug; cleaning and sterilization, the equipment is cleaned in place and in place. Sterilization technology (refers to the function of cleaning or sterilizing the system or mechanism without any movement or change in the original installation position) is a method to effectively control cross-contamination, but requires technical support for equipment structure and control.
(2) Material, appearance and safety design: The material of the manufacturing equipment shall not affect the nature, purity and quality of the drug. It shall be non-toxic, corrosion-resistant and not chemically react with the substance in contact, do not produce adsorption, and do not produce particles. The simplicity of appearance is a prerequisite for achieving complete cleaning or cleaning purposes; safety protection also includes two meanings. First, from the perspective of drug safety, equipment must not change the nature and quality of the drug; second, the safety of equipment operation and operation Protection performance.
(3) Structural design: There are many situations in which the mechanical power components in the equipment are in contact with materials, etc., and it is often difficult to handle the structural design (such as powder mixing, moving shaft sealing, etc.) Pollution). In addition, it involves simple and smooth design, the choice of lubricating structure and lubricant, the partial 100-level air laminar flow purification, the influence of the factors in the use of equipment on the environment and drugs, and the threats. .
(4) Online detection, control and verification: On-line detection and control are conditions for meeting safety and continuous production, and require the application of advanced technologies such as digital display, analysis, recording, program control and alarm. Verification is a documented activity that systematically confirms the quality of the decanter centrifuge. It includes four stages: design confirmation, installation confirmation, operation confirmation and performance verification. The user must pass the above verification and the equipment can be put into use after passing the test. Pharmaceutical equipment manufacturers must pay attention to product design in accordance with GMP during the research and development stage.
(5) Relevant public works: The equipment does not exist independently. The medium (water, gas, steam, etc.) used in the horizontal screw centrifuge and the divergence factors of the equipment also have a non-negligible influence on the safety of the production of the medicine. Similarly, it also involves The interface of the supporting facilities and equipment of the horizontal screw centrifuge (process port, verification port, sampling port, inspection port, etc.).
In the face of GMP, it is hoped that the horizontal screw centrifuge design meets the requirements of “zero defect” in the safe production of drugs, and some requirements are close to the harshness of mechanical structure design.
Such as: (1) the structure of the parts inside the container should have no dead angle of the retained material;
(2) The seal of the moving shaft shall not leak to the material side;
(3) How to implement CIP and SIP;
(4) reduce process exposure;
(5) Avoid cross-contamination caused by process, transfer or equipment operation;
(6) A closed production system that achieves continuous and sterilized “no sunlight”;
(7) Prevent human error.
In terms of the strict requirements of GMP for decanter centrifuges, it has given a large space for research and development and improvement of pharmaceutical equipment structure and function, forming a technological innovation and modern technology application during the 11th Five-Year Plan period. The period of competitive development.